The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

PHASE3TerminatedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

November 24, 2021

Primary Completion Date

December 20, 2023

Study Completion Date

December 20, 2023

Conditions
Ulcerative Colitis
Interventions
DRUG

Cobitolimod 250 mg

Rectal administration

DRUG

Cobitolimod 500 mg

Rectal administration

DRUG

Placebo

Rectal administration

Trial Locations (203)

10075

Lenox Hill Hospital, New York

22031

Gastroenterology Associates of Northern Virginia, Fairfax

27262

Peters Medical Research, High Point

27834

Carolina Research, Greenville

28209

Carolina Digestive Health Associates, PA, Charlotte

33012

A+ Research, Inc., Miami

33136

SouthCoast Research Center, Inc, Miami

33144

I.V.A.M. Clinical & Investigational Center LLC, Miami

33155

D&H National Research Centers, Inc., Miami

33165

Medical Professionals Clinical Research Center, Miami

33172

MB & V Medical Research, Doral

33472

RecioMed Clinical Research Network, Inc., Boynton Beach

33615

Alliance Clinical Research - Gastroenterology, Tampa

34102

Gastroenterology Group Of Naples, Naples

45440

Dayton Gastroenterology, Beavercreek

48098

Clinical Research Institute of Michigan, Troy

53215

Wisconsin Center For Advanced Research, Milwaukee

66606

Cotton O'Neil Clinical Research Center, Topeka

75019

Digestive Health Associates of Texas, PA, Carrollton

77024

Clinical Research Solution: Digestive Health Associates, Houston

77030

Baylor College of Medicine - Gastroeneterology, Houston

91344

Amicis Research Center, Granada Hills

91356

Valiance Clinical Research, Tarzana

91730

Prospective Research Innovations Inc., Rancho Cucamonga

92691

Allameh Medical Corporation, Mission Viejo

Unknown

Monash Health, Clayton

St Vincent's Hospital Melbourne, Fitzroy

The Alfred Hospital, Melbourne

Royal Melbourne Hospital, Parkville

Mater Health Services, South Brisbane

Princess Alexandra Hospital, Woolloongabba

MedUn Innsbruck, Innsbruck

LKH Klagenfurt, Klagenfurt

Universitätsklinikum Salzburg, Salzburg

Akh Wien, Vienna

UZ Antwerpen, Antwerp

Imelda Ziekenhuis, Bonheiden

Erasme University Hospital, Brussels

Universitair Ziekenhuis Gent, Ghent

AZ Groeninge - Campus Kennedylaan, Kortrijk

AZ Delta, Roeselare

University Clinical Centre of the Republic of Srpska - Gastroenterology, Banja Luka

The University Hospital Foca, Foča

Clinical Center University of Sarajevo - Gastroenterology, Sarajevo

"General Hospital Prim.dr.Abdulah Nakas", Sarajevo

Polyclinic Dr. Al-Tawil, Sarajevo

Opca Bolnica Tesanj, Tešanj

Plava Medical Group, Tuzla

Cantonal Hospital Zenica, Zenica

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda, Goiânia

Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica, Porto Alegre

Ufrj - Hospital Universitario Clementino Fraga Filho, Rio de Janeiro

Praxis Pesquisa Medica, Santo André

CEMEC - Centro Multidisciplinar de Estudos Clinicos, São Bernardo do Campo

Kaiser Clinica, São José do Rio Preto

MUMC - Hamilton Health Sciences, Hamilton

Installation Hospital Maisonneuve-Rosemont, Montreal

Royal University Hospital, Saskatoon

Opca bolnica Bjelovar, Bjelovar

Clinical Hospital Osijek, Osijek

Opca bolnica Pula, Pula

Zadar General Hospital, Zadar

Poliklinika Solmed, Zagreb

University Hospital Centre Zagreb, Zagreb

Aalborg University Hospital, Aalborg

Aarhus University Hospital, Aarhus

Herlev Hospital, Herlev

Hillerod Hospital, Hillerød

Lillebælt Hospital Vejle, Vejle

CHRU de Lille - Hôpital Claude Huriez, Lille

CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologie, Montpellier

CHU de Nancy Brabois, Nancy

CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, Hépatologie, Nice

Hopital Bichat - Gastroenterology, Paris

Hopital Saint Antoine, Paris

Centre Hospitalier Lyon Sud, Pierre-Bénite

Centre Hospitalier Universitaire de Poitiers, Poitiers

CHU de Saint Etienne, Hôpital Nord - Service de Gastroentérologie, Saint-Etienne

CHU Amiens - Hopital Sud - Service Hepato-Gastroenterolog, Salouël

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil, Toulouse

"JSC Evex Hospitals", Batumi

LTD Israel-Georgian Medical Research Clinic Helsicore, Tbilisi

Universitätsklinikum Augsburg, Augsburg

Charité - Universitätsmedizin Berlin KöR, Berlin

University Hospital Cologne AöR, Cologne

MVZ Sanaklinikum Duisburg, Duisburg

Universitätsklinikum Erlangen, Erlangen

Agaplesion Markus Krankenhaus, Frankfurt am Main

Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I, Frankfurt am Main

Universitätsklinikum Freiburg, Freiburg im Breisgau

Uniklinik Halle (Saale), Halle

Gastroenterology Outpatient Clinic Prof. Dr. med. Ehehalt, Heidelberg

University Hospital Schleswig-Holstein, Kiel

Universitätsmedizin Mannheim, Mannheim

Medius Klinik Nürtingen, Nürtingen

Universitätsklinikum Rostock, Rostock

Universitätsklinikum Ulm, Ulm

Internistische Praxis Weyhe, Weyhe

Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft., Budapest

Pannónia Magánorvosi Centrum Kft, Budapest

Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika, Budapest

Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Budapest

SzTE Szt-Gy A Orvostud Kar Bel Klin, Szeged

The Barzilai Medical Center, Ashkelon

The Edith Wolfson Medical Center, Holon

Hadassah Medical Organization, Hadassah Medical Center, Ein-, Jerusalem

Shaare Zedek Medical Center, Jerusalem

Galilee Medical Center (Western Galilee Hospital), Nahariya

Kaplan Medical Center, Rehovot

ASST Papa Giovanni XXIII - Cardiologia - Bergamo, Bergamo

AO Brotzu, Cagliari

Universita degli Studi di Firenze - Azienda Ospedaliero - Un, Florence

IRCCS Ospedale San Raffaele, Milan

Azienda Ospedaliera San Gerardo, Monza

AOU di Padova, Padua

Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P, Roma

Policlinico Universitario Agostino Gemelli, Roma

Policlinico Universitario Campus Biomedico, Rome

A.O. Ordine Mauriziano Di Torino, Torino

AOU S. Maria della Misericordia, Udine

Universita degli Studi dell'Insubria - Ospedale di Circolo e, Varese

Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas

Klaipeda Seamen's Hospital, Klaipėda

Republic Klaipeda Hospital, Klaipėda

Panevezio ligonine, Panevezys

Vilniaus Universiteto ligonines Santariskiu Klinikos, Vilnius

Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango

Clinicos Asociados Bocm, S.C., Mexico City

Medical Care and Research S. A. de C. V, Mérida

Centro Regiomontano de Estudios Clinicos Roma SC, Monterrey

Clinical Research Institute S.C., Tlalnepantla

Radboud University Medical Center, Nijmegen

Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR, Ålesund

Akershus Universitetssykehus, Lørenskog

Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8, Tromsø

Vestfold Hjertesenter As, Tønsberg

MPS - MED sp. z o.o., Grudziądz

MZ Badania Slowik Zymla Spolka jawna, Knurów

Centrum Medyczne Plejady, Krakow

Centrum Medyczne PROMED, Krakow

Krakowskie Centrum Medyczne Sp. z o.o., Krakow

Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi, Lodz

Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o., Malbork

Twoja Przychodnia - Opolskie Centrum Medyczne, Opole

Medicome Sp. z o.o., Oświęcim

Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan

ETG Skierniewice, Skierniewice

KO-MED Centra Kliniczne Staszow, Staszów

Twoja Przychodnia - SCM, Szczecin

GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie, Torun

Bodyclinic sp. z o.o. sp.k., Warsaw

Centralny Szpital Kliniczny MSWiA w Warszawie, Warsaw

Centrum Zdrowia Matki, Dziecka i Mlodziezy, Warsaw

PlanetMed, Wroclaw

ETG Zamosc, Zamość

Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra), Amadora

Hospital de Braga, Braga

Hospital Beatriz Angelo (HBA), Loures

Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São Sebastião, Santa Maria da Feira

Sana Monitoring, Bucharest

Spitalul Clinic Colentina, Bucharest

Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Cluj-Napoca

"Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi", Iași

Spitalul Clinic Judetean Mures, Târgu Mureş

Cabinet Particular Policlinic Algomed, Timișoara

Clinic Center of Serbia, Belgrade

"Clinical Hospital Center Dr. Dragisa Misovic", Belgrade

Euromedik Hospital, Belgrade

Zvezdara University Medical Center, Belgrade

Clinical Center Kragujevac - Center for Gastroenterohepatology, Kragujevac

General Hospital Dr Djordje Joanovic, Zrenjanin

General hospital Zrenjanin, Zrenjanin

FNsP F.D.R. Banska Bystrica, Banská Bystrica

CLINIQ s.r.o., Bratislava

ENDOMED s.r.o., Košice

GASTROMEDIC, s.r.o., Nové Zámky

Accout Center s.r.o., Šahy

Inje University Haeundae Paik Hospital, Busan

Kyungpook National University Hospital, Daegu

Hanyang University Guri Hospital, Guri-si

Kyung Hee University Hospital, Seoul

Seoul National University Bundang Hospital, Seoul

Seoul National University Hospital, Seoul

Kyung Hee University Hospital - Internal Medicine, Soeul

Kyung Hee University Hospital, Soeul

The Catholic University of Korea, St. Vincent's Hospital, Suwon

Yonsei University, Wonju Severance Christian Hospital, Wŏnju

Örebro Univ. Hospital, Örebro

Karolinska Universitetssjukhuset - Gastroenterology, Stockholm

Uppsala University Hospital, Akademiska, Uppsala

Hacettepe University Medical Faculty - Hematology, Ankara

Istanbul University Medical Faculty, Istanbul

Mersin Universtiy Medical Faculty, Mersin

Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology, Bury

Accellacare Warwickshire Quality Research Site, Coventry

County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital, Darlington

Glasgow Royal Infirmary, Glasgow

North West London Hospitals NHS Trust, Harrow

Central Middlesex Hospital, London

Kings College Hospital, London

Accellacare North London, Northwood

Accellacare Limited/Accellacare of South London, Orpington

Royal Berkshire Hospital, Reading

Sponsors
All Listed Sponsors
lead

InDex Pharmaceuticals

INDUSTRY